1. Drug Listing of Export Products
According to Annex B of the drug listing instructions (http://www.fda.gov/cder/drls/default.htm)
"The Drug Listing Act applies to all drug firms manufacturing or processing human drugs, veterinary drugs and medicated animal feed premixes. Domestic firms purchasing bulk or finished drugs from foreign companies should inform representatives of those companies that all drugs imported into this country must be listed by the foreign firm or its designated U.S. agent. All drugs exported by domestic firms, whether in bulk or finished dosage forms, must similarly be listed."
If a product is returned from its destination site outside the U.S., then it becomes an issue to list the product.
Follow up with FDA: FDA will look into this matter. However, as long as the regulations are followed, there is no should be no compliance violation.
2. Alpha Numeric FEI number:
Some organizations have FEI numbers that consist of Alphanumeric numbers. These numbers mainly start with "FC" and then what seems to be a character country code followed by three numbers. An SPL file (establishment registration file) will fail validation if it contains alphanumeric characters, so these numbers cannot be used in a submission. For a true list of a company's FEI number, the Drug Firm Annual Registration Database should be consulted (http://www.fda.gov/CDER/dfars/default.htm).
Team member will contact FDA to follow up.
3. De-Listing of Products priot to SPL R.4
Delisting of products prior to the June 1st deadline can be done in paper or if arrangements are made with FDA in advance, a spreadsheet can be submitted to the Agency requesting several products be delisted with their implementation dates. The fields that will need to be included are as follows:
Product name, strength, package, NDC number and discontinuation date. No FDA Form2657 will be needed if this route of delisting is chosen. There is also no time limit on the discontinuation date as long as it is within reason (Can be several years out)
4. Process Question Log
We will begin keeping a tracking log of questions related to processes so that we can bring up issues that we are faced to FDA. This list will be maintained on the WIKI so everyone can have access to it. All participants are encouraged to provide input into the question log.
5. Next meeting - February 18, 2009 at 1 PM Eastern Time.
According to Annex B of the drug listing instructions (http://www.fda.gov/cder/drls/default.htm)
"The Drug Listing Act applies to all drug firms manufacturing or processing human drugs, veterinary drugs and medicated animal feed premixes. Domestic firms purchasing bulk or finished drugs from foreign companies should inform representatives of those companies that all drugs imported into this country must be listed by the foreign firm or its designated U.S. agent. All drugs exported by domestic firms, whether in bulk or finished dosage forms, must similarly be listed."
If a product is returned from its destination site outside the U.S., then it becomes an issue to list the product.
Follow up with FDA: FDA will look into this matter. However, as long as the regulations are followed, there is no should be no compliance violation.
2. Alpha Numeric FEI number:
Some organizations have FEI numbers that consist of Alphanumeric numbers. These numbers mainly start with "FC" and then what seems to be a character country code followed by three numbers. An SPL file (establishment registration file) will fail validation if it contains alphanumeric characters, so these numbers cannot be used in a submission. For a true list of a company's FEI number, the Drug Firm Annual Registration Database should be consulted (http://www.fda.gov/CDER/dfars/default.htm).
Team member will contact FDA to follow up.
3. De-Listing of Products priot to SPL R.4
Delisting of products prior to the June 1st deadline can be done in paper or if arrangements are made with FDA in advance, a spreadsheet can be submitted to the Agency requesting several products be delisted with their implementation dates. The fields that will need to be included are as follows:
Product name, strength, package, NDC number and discontinuation date. No FDA Form2657 will be needed if this route of delisting is chosen. There is also no time limit on the discontinuation date as long as it is within reason (Can be several years out)
4. Process Question Log
We will begin keeping a tracking log of questions related to processes so that we can bring up issues that we are faced to FDA. This list will be maintained on the WIKI so everyone can have access to it. All participants are encouraged to provide input into the question log.
5. Next meeting - February 18, 2009 at 1 PM Eastern Time.